Some severe adverse reactions may be caused by non-compliance with the rate of administration of the drug. It is necessary to strictly follow the recommendations listed in the section "Method of administration and dose".
Patients should be screened for any symptoms of adverse reactions throughout the period of use of the drug.
Adverse reactions are most common:
- at a high rate of drug administration;
- in patients with hypo- or agammaglobulinemia in the presence or absence of concomitant deficiency IgA;
- in patients who are receiving normal human immunoglobulin therapy for the first time, in rare cases, when a human immunoglobulin preparation is normal or in cases of a significant break since the last infusion of the drug.
True hypersensitivity reactions are rare. They can occur in very rare cases of deficiency IgA if the patient has antibodies to IgA.
In rare cases, the use of this drug may lead to a decrease in blood pressure and anaphylactic reactions, even in those patients,who had not previously experienced adverse reactions when using normal human immunoglobulin.
Potential complications are often avoided:
- if the initial slow introduction of human immunoglobulin at a rate not exceeding 0.46-0.92 ml / kg / hour, the patient does not have allergic reactions to normal human immunoglobulin;
- with constant monitoring of the patient throughout the treatment period.
Patients who first use a drug that has previously used another human immunoglobulin preparation or who have a long break from the last infusion should be observed by the attending physician during the administration of the drug, and also within 1 hour after the infusion to establish signs of potential adverse reactions. All other patients should be monitored for at least 20 minutes after drug administration.
It has been clinically established that possible thromboembolic complications, such as myocardial infarction, heart attack, pulmonary embolism and deep vein thrombosis, are presumably due to a relative increase in blood viscosity due to the introduction of a high dose of immunoglobulin to patients at risk.
Should carefully prescribe the drug to patients who are overweight and / or risk of thrombosis (elderly, hypertension, diabetes, vascular disease and thrombosis, acquired or hereditary thrombophilia, prolonged immobilization, severe hypovolemia, increased blood coagulability).
In most cases, the administration of normal human immunoglobulin can cause acute renal failure in a group of patients with previously developed renal insufficiency, diabetes mellitus, hypovolemia, overweight and simultaneous therapy with nephrotoxic drugs or patients older than 65 years. In the event of a violation of the kidneys should stop the drug.
Since the drug contains maltose, it must be taken into account that under the influence of maltose, an imaginary increase in blood glucose levels is possible. In this case, the subsequent appointment of insulin can lead to life threatening hypoglycemia and death.
Information about the violation of kidney function and acute renal failure were obtained during treatment with drugs containing as a stabilizer maltose. For patients at risk, it is recommended that normal human immunoglobulin, which does not contain maltose, and also administer effective doses of the drug at the lowest possible rate.
Cases of aseptic meningitis syndrome in the case of large doses (2 mg / kg), starting from several hours to 2 days after the administration of the drug, with pleiotitosis (mainly granulocytes) and an increase in the level of protein in the cerebrospinal fluid are described.
The introduction of the drug to all patient groups requires:
- preparation of appropriate dilution before administration of the drug;
- control of diuresis;
- monitoring serum creatinine levels;
- avoidance of simultaneous application of loop diuretics.
In case of adverse reactions, the rate of infusion should be reduced or the administration should be discontinued. The resumption of treatment depends on the nature and severity of the side effects.
In the event of shock, anti-shock therapy should be performed.